冠状动脉支架术后阿托伐他汀或普伐他汀与氯吡格雷联合治疗的近期疗效比较——随机对照试验

目的 比较冠状动脉支架术后通过肝细胞色素P450(CYP)3A4代谢的阿托伐他汀和不通过CYP3A4代谢的普伐他汀与氯吡格雷联合应用的近期疗效,探讨二者对氯吡格雷抗血小板作用的影响.方法 收集2006年2月-2007年3月在沈阳军区总医院成功实施冠脉支架术的住院冠心病患者共1250例,术后随机接受阿托伐他汀20mg/d(n＝638)或普伐他汀20mg/d(n＝612),两组患者均接受常规剂量氯吡格雷治疗.研究主要终点为30d主要不良心脑血管事件(MAACCE),包括心性死亡、非致死性心肌梗死(MI)、卒中及紧急靶血管血运重建(UTVR).次要终点为亚急性血栓形成(SAT)及出血事件.结果 两组临床基线资料、冠脉造影及PCI结果无统计学差异.30d时,阿托伐他汀组心性死亡、非致死性MI、UTVRr、脑卒中发生率(分别为0.47%、0.47%、1.41%、0.16%)与普伐他汀组(分别为1.14%、0.49%、1.14%、0.33%)比较无统计学差异(P＞0.05).阿托伐他汀组MACCE、SAT发生率(分别为2.51%、0.16%)与普伐他汀组(分别为3.10%、0.16%)比较亦无统计学差异(P＝0.523或P＝1.000).两组出血事件发生率分别为2.51%和2.12%,差异无统计学意义(P＝0.652).Kaplan-Meier生存分析显示阿托伐他汀组与普伐他汀组累积风险率无显著差异(P＝0.523).结论 冠状动脉支架术后患者采用阿托伐他汀20mg/d或普伐他汀20mg/d联合氯吡格雷治疗的近期疗效相近,长期疗效和安全性还需进一步观察.

Comparison on the short-term effects of atorvastatin or provastatin combined with clopidogrel for patients undergoing coronary stenting: a randomized controlled trial

Objective To evaluate the short-term therapeutic effects of atorvastatin via cytochrome P450(CYP)3A4 pathway or a non-CYP 3A4 statin,provastatin,combined with clopidogrel for the patients undergoing coronary stenting.Methods From February 2006 to March 2007,a total of 1 250 hospitalized patients undergoing coronary stenting were randomly given atrovastatin 20mg/d(638 patients)or provastatin 20mg/d(612 patients).All patients received standard clopidogrel therapy.The primary end point was major adverse cardiac and cerebral events(MACCE)at 30 days,defined as the composite of cardiac death,non-fatal myocardial infarction(MI),stroke or urgent target vessel revascularization(UTVR).The second end point were sub-acute instent thrombosis(SAT)and hemorrhagic events.Results The baseline clinical characteristics,angiography and PCI result were comparable between the two groups.No significant difference existed in cardiac death rate(0.47% vs 1.14%),non-fatal MI(0.47% vs 0.49%),UTVR(1.41% vs 1.14%)and stroke(0.16% vs 0.33%,P>0.05),as well as in the composite of MACCE(2.51% vs 3.10%,P=0.523)between the two groups.Also,no significant difference existed in the rate of SAT(0.16% vs 0.16%,P=1.000)and hemorrhagic events(2.51% vs 2.12%,P=0.652)between the two groups.Kaplan-Meier survival analysis showed the cumulative hazard rate for the MACCE was similar(P=0.523).Conclusions Short-term therapeutic effects of atorvastatin 20mg/d combined with clopidogrel for the patients undergoing coronary stenting is similar to that of provastatin combined with clopidogrel.Long-term therapeutic efficiency and safety of the two strategies need to be further investigated.